PsoriasisBostripNCT01403012
BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis
An observational study of Psoriasis, run by Technical University of Munich at 1 site in Germany.
Trial summary
Metabolomics of systemic psoriasis treatment Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Withdrawal of venous blood samples
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to 4 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psoriasis patients
Who may be able to join
- Male and female patients aged 18 - 80 years, body weight ≤ 180 kg
- Dermatological diagnosis of psoriasis
- Initiated therapy with TNFα-inhibitor agents (etanercept, adalimumab and infliximab)or fumaric acid ester (FAE) within the scope of routine patient care by treating physician
- Signed informed consent from patient
Who cannot join
- Patients with evidence of any skin condition that would interfere with the evaluation of psoriasis
- Use of systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within 30 days of Visit 1 or used FAE or other any biologic agent such as etanercept, infliximab and adalimumab within 12 weeks prior to Visit 1
- Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
- Patients who are unable to complete a patient diary or complete questionnaires on paper
- Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule
- Pregnancy or breast feeding women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use effective contraception during the study. Effective contraception is defined as either: use of established oral, injected or implanted hormonal
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology and Allergy, Uniklinik Kiel
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Differential Analysis of Metabolomic Profiles in Patients With Chronic Plaque Psoriasis Undergoing Systemic Treatment
Metabolomics of systemic psoriasis treatment
- Conditions
- Psoriasis
- Being tested
- Withdrawal of venous blood samples
- Keywords
- To identify clinical and metabolomic markers that underlie variability in response to systemic therapy in psoriasis, To identify metabolomic signatures associated with psoriasis, To identify possible treatment-specific metabolomic signatures
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal of venous blood samplesOther
Withdrawal of venous blood samples (approx. 20 ml) and 2 skin biopsies (5 mm)
Laboratory measurements:
Fasting serum concentrations of 200 metabolites covering a biologically relevant panel of amino acids, sugars, acylcarnitines and phospholipids Genome-wide expression profiles generated from RNA derived from peripheral leukocytes
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of metabolic profiles associated with treatment response
The primary aim of this study is to analyze metabolic profiles as well as expression data in patients with chronic plaque psoriasis undergoing systemic treatment with TNF_-inhibitor agents (etanercept, adalimumab, infliximab) and fumaric acid ester (FAE) in order to identify clinical and metabolomic markers that underlie variability in response to therapy.
Measured: week 0 and week 12
Secondary outcomes (1)
Identification of metabolomic signatures associated with psoriasis
The secondary aim is to identify metabolomic signatures associated with psoriasis and to identify possible treatment-specific metabolomic signatures.
It is anticipated, to get insights into mechanisms of anti-TNF drug action and response as well as first indications for metabotypes that are associated with psoriasis. In addition, genetic variants correlated to these metabotypes might be identified.
Measured: week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startAug 2011
- Primary completion19 Nov 2014
- Study completion4 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Weidinger, Dr. med., Principal investigator, Dermatology, University Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403012
- Sponsor's protocol ID
- BOS-1168-WEI-0080-I
- Acronym
- Bostrip
- Status last verified
- Oct 2019
- First submitted
- 8 Jul 2011
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Analysis of Metabolomic Profiles in Patients With Chronic Plaque Psoriasis Undergoing Systemic Treatment
- ClinicalTrials.gov ID
- NCT01403012
- Acronym / sponsor ID
- Bostrip / BOS-1168-WEI-0080-I
- Conditions
- Psoriasis
- Keywords
- To identify clinical and metabolomic markers that underlie variability in response to systemic therapy in psoriasis, To identify metabolomic signatures associated with psoriasis, To identify possible treatment-specific metabolomic signatures
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- 19 Nov 2014 (actual)
- Study completion
- 4 Dec 2015 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolomics of systemic psoriasis treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psoriasis patients
Key inclusion criteria (4 listed)
- Male and female patients aged 18 - 80 years, body weight ≤ 180 kg
- Dermatological diagnosis of psoriasis
- Initiated therapy with TNFα-inhibitor agents (etanercept, adalimumab and infliximab)or fumaric acid ester (FAE) within the scope of routine patient care by treating physician
- Signed informed consent from patient
Key exclusion criteria (7 listed)
- Patients with evidence of any skin condition that would interfere with the evaluation of psoriasis
- Use of systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within 30 days of Visit 1 or used FAE or other any biologic agent such as etanercept, infliximab and adalimumab within 12 weeks prior to Visit 1
- Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
- Patients who are unable to complete a patient diary or complete questionnaires on paper
- Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withdrawal of venous blood samplesWithdrawal of venous blood samples (approx. 20 ml) and 2 skin biopsies (5 mm) Laboratory measurements: Fasting serum concentrations of 200 metabolites covering a biologically relevant panel of amino acids, sugars, acylcarnitines and phospholipids Genome-wide expression profiles generated from RNA derived from peripheral leukocytes | Other | – |
Primary outcome
Analysis of metabolic profiles associated with treatment response
Time frame: week 0 and week 12
The primary aim of this study is to analyze metabolic profiles as well as expression data in patients with chronic plaque psoriasis undergoing systemic treatment with TNF_-inhibitor agents (etanercept, adalimumab, infliximab) and fumaric acid ester (FAE) in order to identify clinical and metabolomic markers that underlie variability in response to therapy.
1 secondary outcome
Identification of metabolomic signatures associated with psoriasis
Time frame: week 0 and week 12
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Weidinger, Dr. med. principal investigator
Dermatology, University Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of metabolic profiles associated with treatment response (time frame: week 0 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.